CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 43 enrolled
Drug / intervention
Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)drug
Likely dose
Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) 300 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04298697
NCT04298697Phase 4Completed
CompareCT.gov

Biomarkers for Event-driven PrEP Adherence

Emory University·interventional·Posted Mar 6, 2020·Updated Sep 19, 2024

In Brief

A Phase 4 clinical trial evaluating Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) for Human Immunodeficiency Virus. Completed, enrolled 43 participants across 1 site.

Detailed Summary

This study aims to recruit 40 participants who will take the combination anti-HIV drug tenofovir+emtricitabine (TDF/FTC) at specified times. Participants will then provide biologic samples for the measurement of anti-retroviral drug concentrations in various body compartment sites. Participants will be involved in the study for up to 24 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHuman Immunodeficiency Virus
CountriesUnited States
CollaboratorsCenters for Disease Control and Prevention

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedMar 6, 2020
Enrollment StartFeb 28, 2020
Primary CompletionAug 9, 2022
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 6.3 years ago

Interventions

Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)drug

TDF/FTC is a combination anti-HIV medication that contains the drugs tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg). Participants will take 2 pills on the first day of the week and one pill per day on the second and third days of the week, according to the dosing schedule of the study arm they are in. Participants will have biologic specimens collected at specific time points until 28 days after the last dose.